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BMJ 2012;344:e2333 doi: 10.1136/bmj.

e2333 (Published 26 April 2012) Page 1 of 12

Research

RESEARCH

Effectiveness of a diabetes education and self


management programme (DESMOND) for people with
newly diagnosed type 2 diabetes mellitus: three year
follow-up of a cluster randomised controlled trial in
primary care
OPEN ACCESS

1
Kamlesh Khunti professor of primary care diabetes and vascular medicine , Laura J Gray lecturer
1 2
of population and public health sciences , Timothy Skinner director rural clinical school , Marian E
3 3
Carey national director; DESMOND programme , Kathryn Realf research assistant , Helen Dallosso
3 1
research associate , Harriet Fisher research assistant , Michael Campbell professor of medical
4 5
statistics , Simon Heller professor of clinical diabetes , Melanie J Davies professor in diabetes
6
medicine
1
Department of Health Sciences, University of Leicester, Leicester LE1 6TP, UK; 2Rural Clinical School, University of Tasmania, Tasmania, Australia;
3
Diabetes Research, University Hospitals of Leicester, Leicester, UK; 4Health Services Research, ScHARR, University of Sheffield, Sheffield, UK;
5
Department of Human Metabolism, University of Sheffield, Sheffield, UK; 6Department of Cardiovascular Sciences, University of Leicester

Abstract Results HbA1c levels at three years had decreased in both groups. After
Objective To measure whether the benefits of a single education and adjusting for baseline and cluster the difference was not significant
self management structured programme for people with newly diagnosed (difference 0.02, 95% confidence interval 0.22 to 0.17). The groups
type 2 diabetes mellitus are sustained at three years. did not differ for the other biomedical and lifestyle outcomes and drug
use. The significant benefits in the intervention group across four out of
Design Three year follow-up of a multicentre cluster randomised
five health beliefs seen at 12 months were sustained at three years
controlled trial in primary care, with randomisation at practice level.
(P<0.01). Depression scores and quality of life did not differ at three
Setting 207 general practices in 13 primary care sites in the United years.
Kingdom.
Conclusion A single programme for people with newly diagnosed type
Participants 731 of the 824 participants included in the original trial 2 diabetes mellitus showed no difference in biomedical or lifestyle
were eligible for follow-up. Biomedical data were collected on 604 outcomes at three years although there were sustained improvements
(82.6%) and questionnaire data on 513 (70.1%) participants. in some illness beliefs.
Intervention A structured group education programme for six hours Trial registration Current Controlled Trials ISRCTN17844016.
delivered in the community by two trained healthcare professional
educators compared with usual care. Introduction
Main outcome measures The primary outcome was glycated
Type 2 diabetes mellitus is a serious, progressive condition
haemoglobin (HbA1c) levels. The secondary outcomes were blood
presenting with chronic hyperglycaemia, and its prevalence is
pressure, weight, blood lipid levels, smoking status, physical activity,
increasing globally. In the short term, type 2 diabetes may lead
quality of life, beliefs about illness, depression, emotional impact of
to symptoms and debility and in the long term to serious
diabetes, and drug use at three years.
complications, including blindness, renal failure, and
amputation.1 Furthermore, three quarters of people with type 2

Correspondence to: K Khunti kk22@le.ac.uk


Extra material supplied by the author (see http://www.bmj.com/content/344/bmj.e2333?tab=related#webextra)
Quality of life data at three years

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BMJ 2012;344:e2333 doi: 10.1136/bmj.e2333 (Published 26 April 2012) Page 2 of 12

RESEARCH

diabetes will die from cardiovascular disease.2 Traditionally, cluster randomised controlled trial was undertaken to assess the
treatment for the condition has centred on drug interventions to effectiveness of a structured self management education
stabilise hyperglycaemia and to manage cardiovascular risk programme that took place in 13 primary care sites (207
factors, including blood pressure and lipids, to prevent associated practices) across England and Scotland. Randomisation took
symptoms and reduce the risk of vascular complications over place at the level of the general practice to minimise
time.3 Long term follow-up data from the United Kingdom contamination between participants, with stratification by
Prospective Diabetes Study has shown that despite early training status and type of contract with the primary care
successes, metabolic control progressively worsens with time, organisation (General Medical Services or Personal Medical
warranting exploration of alternative approaches for long term Services). Randomisation was undertaken independently at the
management of type 2 diabetes.4 University of Sheffield using Random Log. At each site a local
Anyone with diabetes, including type 2 diabetes, has to make coordinator oversaw the trial, recruited and trained practices,
multiple daily choices about the management of their condition, and maintained contact with practice staff. Performance of the
such as appropriate dietary intake, physical activity, and sites and local coordinators was monitored regularly, with each
adherence to drugs, often with minimal input from a healthcare site receiving a visit before the trial and a minimum of one
professional.5 In recent years, programmes to educate people monitoring visit per year. Practice staff sent biomedical data to
about self management have become the focus of attention the local coordinator for forwarding to the central coordinating
among healthcare professionals and are advocated for people centre.
with type 2 diabetes as a means to acquire the skills necessary Individuals were referred within six weeks of diagnosis to the
for active responsibility in the day to day self management of study, with those in the intervention arm attending a structured
their condition.6-10 In addition, it has been suggested that education programme within 12 weeks of diagnosis. Participants
education on self management may play a pivotal role in tackling in the original trial were excluded if they were aged less than
beliefs about health and so improve metabolic control, 18 years, had severe and enduring mental health problems, were
concordance with drug decisions, risk factors, and quality of not primarily responsible for their own care, were unable to
life.11-13 participate in a group programme (for example, were
Globally, self management education is recognised as an housebound or unable to communicate in English), or were
important component for the management of type 2 diabetes; participating in another research study. Recruitment took place
the American Diabetes Association states that it should be between October 2004 and January 2006. Everyone who
offered from the point of diagnosis.14 Similarly in the United consented to join the original trial was eligible for follow-up at
Kingdom, where this study was undertaken, the 2008 National three years unless they had withdrawn during the trial or their
Institute for Health and Clinical Excellence guidelines for practice informed us they were no longer at the practice or that
diabetes,15 national service framework for diabetes,9 and the it would be inappropriate to contact them (for example, owing
2011 quality standards from NICE, advocate the provision of to serious illness).
self management education from diagnosis. The diabetes
education and self management for ongoing and newly The intervention
diagnosed (DESMOND) intervention was one of the first The structured group education programme is based on a series
programmes to meet the quality criteria for education of psychological theories of learning: Leventhals common
programmes that are listed by the Department of Health and sense theory,22 dual process theory,23 and social learning theory.24
Diabetes UK Patient Working Group, which are consistent with The philosophy of the programme was founded on patient
the American Diabetes Association criteria.16 DESMOND is empowerment, as evidenced in published work.25 26
currently available in 103 health organisations across the United
The intervention was devised as a group education programme,
Kingdom, Republic of Ireland, Gibraltar, and Australia, with
with a written curriculum suitable for a wide range of
735 trained educators.
participants, delivered in a community setting, and integrated
The study design, baseline characteristics of the participants, into routine care. Registered healthcare professionals received
and changes in biomedical, lifestyle, and psychosocial measures formal training to deliver the programme and were supported
at 12 months have been reported and showed improvements in by a quality assurance component of internal and external
weight, smoking cessation, illness beliefs, depression, and assessment to ensure consistency of delivery. The programme
cardiovascular risk scores in participants who received the was six hours long, deliverable in either one full day or two half
intervention compared with standard care.17-19 The programme day equivalents, and facilitated by two educators. Learning was
has recently been shown to be cost effective.20 elicited rather than taught, with the behaviour of the educators
Few self management education programmes have reported promoting a non-didactic approach. Most of the curriculum
long term effects of the intervention.21 Self management focused on lifestyle factors, such as food choices, physical
education programmes, such as DESMOND, may incur benefits activity, and cardiovascular risk factors. The programme
to participants in the longer term, as participants who activates participants to consider their own personal risk factors
successfully acquire, embrace, and maintain the necessary skills and, in keeping with theories of self efficacy, to choose a
for the self management of their condition may gain further specific achievable goal to work on.24 The broad content of the
benefits in terms of biomedical and psychosocial outcomes. We curriculum and an overview of the quality assurance have been
evaluated whether the impact of a single structured self reported elsewhere.17
management education programme (DESMOND) with six hours The methods followed for the present study were similar to
contact time within six weeks of diagnosis was sustained at those of the original trial. Participants were sent a postal
three years. questionnaire two weeks before the three year follow-up date.
A reminder letter and further copy of the questionnaire were
Methods sent if the original questionnaire was not returned within three
weeks. Practices were contacted at the same time and asked to
The study methods, intervention, and outcomes at 12 months forward the most recent biomedical measurements on the
have been reported in detail previously.18 19 Briefly, a robust
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BMJ 2012;344:e2333 doi: 10.1136/bmj.e2333 (Published 26 April 2012) Page 3 of 12

RESEARCH

participants to see if differences to biomedical and psychosocial and 237 (68.5%) for the control arm. Table 1 compares the
outcomes could be sustained at three years. Given the nature of baseline characteristics of those who were and were not
the original intervention, the study was not blinded. successfully followed up at three years. The group on whom
three year follow-up data were obtained were older (P=0.01)
Outcome variables and had a lower weight (P=0.004), body mass index (P=0.004),
waist circumference (P<0.001), and depression score (P<0.001).
Follow-up took place at four, eight, and 12 months and at three
When taking into account the treatment group, no interactions
years, with biomedical, lifestyle, and psychosocial data being
between responders and group were found for these outcomes.
collected. Biomedical outcomes included glycated haemoglobin
(HbA1c) level, blood pressure, levels of total cholesterol, high
density lipoprotein cholesterol, low density cholesterol, and Biomedical outcomes
triglycerides, body weight, and waist circumference. Table 2 shows the mean (95% confidence interval) change in
Questionnaires (described in detail in18) included lifestyle biomedical outcomes in the study groups at three years. Across
questions on smoking status and physical activity, as well as all biomedical outcomes improvements were seen in both
quality of life and health related quality of life. We used an groups, with no significant differences between groups at three
illness perceptions questionnaire27 to assess peoples perception years. The primary outcome, HbA1c level, did not differ
that they understood their diabetes (coherence), perception of significantly between the groups. The observed difference
the duration of their illness (timeline), and perception of their between intervention groups was 0.02 (95% confidence interval
ability to affect the course of their diabetes (personal control). 0.22 to 0.17) after adjusting for baseline and clustering. The
In addition, we collected data on perceived seriousness and intraclass correlation for HbA1c at three years was 0.02 (95%
perceived impact of diabetes, emotional distress specific to confidence interval 0.00 to 0.08).
diabetes using the problem areas in diabetes questionnaire,28 At three years, no statistical difference was seen in 10 year
and depression. coronary heart disease or cardiovascular risk (United Kingdom
Prospective Diabetes Study) between the intervention and
Statistical analysis control groups, with reductions observed in both groups (table
For the original study the sample size was calculated on the 2).
basis of a standard deviation of HbA1c levels of 2%, an intraclass
correlation of 0.05, and an average of 18 participants per Lifestyle outcomes
practice. We calculated that we needed 315 participants per A significant difference in the proportion of non-smokers was
study arm to detect a clinically relevant difference in HbA1c seen in favour of the intervention arm at 12 months. This
levels of 1% at 12 months, with 90% power at the 5% difference was not maintained at three years. No difference in
significance level. Assuming a failure to consent rate of 20% the level of physical activity between the groups was seen at
(not eligible as well as declining to participate) and a dropout three years (P=0.58, table 3).
rate of 20%, 1000 participants (500 in each arm) needed to be
referred. Illness beliefs, depression, problem areas in
Statistical analysis was carried out by intention to treat. diabetes, and quality of life
Continuous variables are given as means and standard deviations
Table 4 shows the results for the psychosocial measures. After
or medians and interquartile ranges and categorical variables
adjustment for baseline value and cluster, four of the five illness
as counts and percentages. To adjust for cluster we used robust
belief scores (coherence, timeline, personal responsibility, and
generalised estimating equations with an exchangeable
seriousness) differed significantly at three years. The
correlation structure. For binary outcomes we used a logit link
intervention participants had higher scores for all, showing that
with a binomial distribution for the outcome, and for continuous
they had a greater understanding of their illness and its
outcomes we used an identity link with a normal distribution.
seriousness and a better perception of the duration of their
Adjustment for baseline value was made in all models (apart
diabetes and of their ability to affect the course of their disease.
from the problem areas in diabetes score, which was not
No difference was seen between the groups for depression,
recorded at baseline as it was inappropriate for participants with
problem areas in diabetes scores, and quality of life at three
newly diagnosed type 2 diabetes). We assumed data to be
years (see supplementary file on bmj.com for quality of life
missing completely at random and they were not replaced or
data).
imputed. Statistical significance was set at 5%, with no
adjustment for multiple testing, although all P values were
interpreted in line with the pattern of the results. All analysis
Drugs
was carried out in Stata (version 10.0). At three years the number of people taking oral antidiabetic
agents as monotherapy or dual therapy or those taking insulin
Results did not differ significantly between the groups (table 5).

Of the 824 individuals who consented to take part from the 207 Discussion
general practices (387 control and 437 intervention) to the
original trial, 743 (90.2%) were eligible for follow-up at three After three years the impact of a single structured education
years. Of those not eligible, 26 died, 44 withdrew from the study, intervention delivered to people with newly diagnosed type 2
16 moved practice, and seven were identified by practices as diabetes mellitus was not sustained for biomedical and lifestyle
being too ill to follow up (figure). Biomedical data were outcomes, although some changes in illness beliefs were still
collected on 604 (82.6%) of those eligible. Biomedical data was apparent.
provided for 332 (85.6%) participants in the intervention arm Previously we reported that compared with baseline at 12
and 272 (79.3%) in the control arm. Postal questionnaires were months HbA1c levels decreased by 1.49% (95% confidence
completed by 536 (73.1%) of those eligible. The level of return intervals 1.69% to 1.29%) in the intervention group and by
for the questionnaires was 299 (75.3%) for the intervention arm 1.21% (1.40% to 1.02%) in the control group.18 The present
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RESEARCH

study showed a small increase in HbA1c levels from the 12 month remain cost effective as the cost effectiveness analysis of the
data; however, overall the decreases in both the intervention DESMOND intervention using 12 month data was based on the
group (1.32%, 1.57% to 1.06%) and the control group assumption that observed lifestyle changes and smoking
(0.81%, 1.02% to 0.59%) were sustained at three years. cessation would not be sustained without an ongoing
Although this is reassuring compared with the long term maintenance intervention.20 We have shown that delivery of the
follow-up results of the United Kingdom Prospective Diabetes DESMOND intervention at diagnosis is beneficial for
Study, which reported a 1% increase in HbA1c level over four psychosocial outcomes. Although these benefits are important
years in a newly diagnosed cohort,4 this is not entirely it remains uncertain at what stage, if ever, biomedical benefits
unexpected in the context of the recent improvements to the emerge in people with newly diagnosed type 2 diabetes and
management and quality of care of type 2 diabetes after the whether in the longer term a relation between the two translates
introduction of the quality outcomes framework.29 A pragmatic, into more effective self management to maintain glycaemic
cluster randomised study undertaken in primary care, control. Participants may need further education and ongoing
ADDITION-Europe, was unable to detect cardiovascular benefit support to successfully manage their condition and to achieve
of multifactorial therapy compared with routine care in people improvements to clinical outcomes and self management
with type 2 diabetes detected by screening. This is thought to behaviours long term.
be at least in part attributable to changes to national guidelines
during the follow-up period of the trial, resulting in allocated Comparison with other studies
treatments of the intervention and control group becoming more Evidence of the long term impact of structured education
similar.30 The clear benefits of an intervention above routine interventions in people with diabetes is currently lacking. The
care has become increasingly difficult to show in a setting where dose adjustment for normal eating (DAFNE) intervention
outcome measures are often successfully treated to target from delivered as a single structured education programme to a group
diagnosis. However, other important aspects of diabetes of adults with type 1 diabetes showed clinically significant
management are not currently captured or incentivised by current improvements to HbA1c levels without an increase in severe
targets, including self management skills and empowerment, hypoglycaemia at two years.32 Quality of life and improvements
which were evaluated in this study.29 to HbA1c levels were maintained at four years.33 The authors
A report of the best methods for evaluating diabetes education suggest that follow-up support for this population group may
identified four key outcomes associated with optimal adjustment create additional benefits by helping people to identify routines
to living with diabetes, which comprised knowledge and to better integrate this regimen into their lives.
understanding, self management, self determination, and The expert patient education versus routine treatment (X-PERT)
psychological adjustment, two of which were assessed in this programme reported significant improvements to HbA1c level
study.31 The significant improvements to four of the five illness at 14 months (0.6% v 0.1%) in a population with established
beliefs were sustained at three years and indicate a greater type 2 diabetes, although long term results have not yet been
understanding by the participants of their diabetes and of their reported.34 Participants of the X-PERT programme had a mean
ability to affect the course of their diabetes. Although duration of 6.7 years, compared with our newly diagnosed cohort
participants from the intervention group believed their diabetes in whom additional benefits of an education programme were
to be more serious and were more likely to agree that they would hard to show when medical outcomes were aggressively and
have diabetes for life, this had not caused them greater distress successfully targeted. An additional dissimilarity is that the
about their diabetes, as evidenced by responses to the problem X-PERT intervention was delivered over six sessions with
areas in diabetes questionnaire. Further research is required to participants receiving double the contact time as those of the
ascertain how to translate these into favourable biomedical DESMOND intervention, which may confer additional benefits.
outcomes in the longer term.
The rethink organisation to improve education and outcomes
Since the launch of the DESMOND programme, numerous (ROMEO) intervention was delivered in a secondary care clinic
studies have aimed to improve self management in people with setting in Italy as a continuous education programme. Long
type 2 diabetes. A recent meta-analysis assessing the impact of term outcomes at four years have reported favourable clinical,
self management interventions in people with type 2 diabetes cognitive, and psychological outcomes in a cohort with
published before 2007 reported improvements to glycaemic established type 2 diabetes.35 The intervention comprised one
control in people who received self management treatment, with hour education sessions delivered on a three monthly basis,
a small advantage of an intervention with an educational whereas the DESMOND module was delivered as a single
approach.21 The results of the DESMOND intervention published intervention involving six hours of contact time, with no further
in 2008 were not included in the meta-analysis. Of the studies reinforcement of the messages delivered. The ROMEO
included in the review, only eight reported follow-up results at intervention implies that an ongoing model of education and
greater than 12 months. care can result in improvements to clinical outcomes. However,
The DESMOND intervention for people with newly diagnosed further research is required to ascertain whether these results
type 2 diabetes was always intended to be included within an are replicable out of the Italian secondary care clinical setting.
ongoing model of education and clinical care, integrating life A self management intervention delivered in a primary care
long learning, care planning, and treatment optimisation. setting in Sweden showed an adjusted difference in HbA1c level
However, a key aspect of the study design was to show at what of 1.37% (P<0.001) at five years between intervention and
point any benefits of intervention begin to diminish. Currently, control groups.36 The intervention group received 10 group
our group are developing and implementing the DESMOND sessions, two hours long, over a period of nine months. The
ongoing module to evaluate the long term effectiveness of an intervention did not have a curriculum or agenda, and whether
ongoing self management intervention in people with type 2 the impressive study results can be replicated has yet to be
diabetes. The findings of these studies will help to determine determined.
the optimal contact time and frequency of education sessions
As with all educational interventions, DESMOND is a complex
required to sustain improvements to clinical outcomes through
intervention, which makes it difficult to ascertain the active
self management. The DESMOND intervention is likely to
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RESEARCH

components contributing to positive effects of the intervention.37 improvements to biomedical outcomes, and further research to
One aspect of the DESMOND intervention is goal setting, where establish this is needed. Future studies need to incorporate a
the participant chooses one part of their care to work at. The longer follow-up period to generate understanding of
relative success of this component, as with others, is currently intervention effects over time.
unknown in the DESMOND intervention. A randomised
controlled trial that evaluated the impact of goal setting in self We thank the National Institute for Health Research Collaboration for
management education in people with type 2 diabetes recently Leadership in Applied Health Research and CareLeicestershire,
reported that at 12 months statistically significant favourable Northamptonshire, and Rutland, and the Biomedical Research Unit.
differences in HbA1c levels were seen in the intervention group.38 Contributors: KK was the principal investigator of the three year follow-up
study and drafted the paper. LG analysed the data and drafted the
Strengths and limitations of the study paper. TCS was involved in the conception of the DESMOND
The original DESMOND trial has several strengths, which have programme and reviewed the paper. MEC was the project manager of
been discussed at length previously.18 In brief, the trial had a the 12 months DESMOND trial and reviewed the paper. KR collated
robust cluster randomised design, with reasonably well matched the data. HD was senior researcher and collated data and drafted the
participants in the control and intervention groups, and the study paper. HF drafted the paper. MC was involved in the design, analysis,
was successful in minimising contamination between practices. and interpretation of the data. SH was involved in the conception of the
Importantly, the intervention was designed for consistent DESMOND programme and reviewed the paper. MJD was the principal
reproducibility of training and had a relatively low up-front investigator for the DESMOND trial, designed the trial, and reviewed
training investment, enabling implementation across other sites. the paper.
All educators participating in the intervention were fully trained Funding: This study was funded by a grant from Diabetes UK secured
and quality assured, ensuring generalisability of the findings in by a joint team from Leicester University and the University Hospitals
other DESMOND studies and out of the research setting. of Leicester NHS Trust. The writing of the report and the decision to
Statistical analyses for this study were undertaken using submit the article for publication was entirely independent of the funder.
intention to treat analysis, minimising bias in the reported The study funder had no input into the study design or analysis, nor the
findings. However, our study may have been underpowered to interpretation of data.
detect improvements in clinical outcomes and as a result some Competing interests: All authors have completed the ICMJE uniform
of our findings may be prone to type 2 error. Response rates of disclosure form at www.icmje.org/coi_disclosure.pdf (available on
the study were higher than expected after three years of request from the corresponding author) and declare: no support from
follow-up, with collection of biomedical data achieved by 83% any company for the submitted work; no financial relationships with any
of participants and questionnaire data by 70%, minimising companies that might have an interest in the submitted work in the
missing data and the effect this may have had on the previous three years; no other relationships or activities that could appear
interpretation of the study results. This compares positively with to have influenced the submitted work.
other self management education interventions that obtained Ethical approval: This study was approved by the Huntingdon local
long term follow-up data from 63% to 85% of the original research ethics committee and was carried out in accordance with the
participants.33 35 36 Those who were followed up at three years principles of the 1996 Helsinki declaration.
were older, healthier, and less depressed at baseline than those Data sharing: No additional data available.
who were not followed up. This selection bias should be
considered when interpreting the results, although importantly 1 Massi-Benedetti M. The cost of diabetes type ii in Europe: the CODE-2 study. Diabetologia
there was no interaction with intervention group. Additionally, 2002;45:S1-4.
2 Tapp R, Shaw J, Zimmet P, eds. Complications of diabetes. In: International diabetes
missing data on individuals may have less impact in a cluster federation, ed. Diabetes atlas. 2nd ed.International Diabetes Federation, 2003.
randomised trial than in an individually randomised trial. 3 Norris S, Nichols P, Caspersen C, Glasgow R, Engelgau M, Jack L. Increasing diabetes
self management education in community settings. A systematic review. Am J Prev Med
A weakness of our study was lack of power to find differences 2002;22:39-66.
in hard end points and that significant differences in mortality 4 UK Prospective Diabetes Study Group. Intensive blood-glucose control with sulphonylureas
or insulin compared with conventional treatment and risk of complications in patients with
or cardiovascular events were unlikely to be detected in this type 2 diabetes (UKPDS 33). Lancet 1998;352:837-53.
study. In reality, intervention studies that report decreases in 5 Jarvis J, Skinner T, Carey M, Davies M. How can structured self-management patient
education improve outcomes in people with type 2 diabetes? Diabet Obes Metab
cardiovascular mortality and morbidity in people with type 2 2010;12:12-9.
diabetes require longer follow-up.39 40 Studies designed with 6 Rutten G. Diabetes patient education: time for a new era. Diabet Med 2005;22:671.
7 National Institute for Health and Clinical Excellence. Guidance on the use of patient
sufficient power to detect differences in these important education models for diabetes (technology appraisal 60). NICE, 2003.
outcomes will provide valuable information to shape the model 8 Department of Health. National service framework for diabetes: delivery strategy.

of future diabetes care. A non-response bias was detected in 9


Department of Health, 2002.
Department of Health. National service framework for diabetes: standards. Department
this study, with responders being older, less overweight of Health, 2001.
(according to body mass index and waist circumference), and 10 Audit Commission. Testing times. A review of diabetes services in England and Wales.
Belmont Press, 2000.
reporting more depressive symptoms. 11 Norris S, Lau J, Smith S, Schmid C, Engelgau M. Self management education for adults
with type 2 diabetes: a meta analysis of the effect on glycemic control. Diabetes Care
2002;25:1159-71.
Conclusion 12 Skinner T, Cradock S, Arundel F, Graham W. Four theories and a philosophy: self
management education for individuals newly diagnosed with type 2 diabetes. Diabetes
In a cohort of adults with newly diagnosed type 2 diabetes a Spectrum 2003;16:75-80.
single, six hour structured programme in self management did 13 Lorig K. Partnerships between expert patients and physicians. Lancet 2002;359:814-5.
14 American Diabetes Association. Position statement: standards in diabetes care. Diabetes
not offer sustained benefits in biomedical outcome measures Care 2010;33:S11-61.
and lifestyle outcomes at three years, but some changes to illness 15 National Institute for Health and Clinical Excellence Guidance 87. Type 2 diabetes: the

beliefs were sustained. The results support a programme of an 16


management of type 2 diabetes (partial update). NICE, 2009.
Department of Health, Diabetes UK. Structured patient education in diabetes: report from
ongoing model of education, although the optimum interval and the Patient Education Working Group. Department of Health, 2005.
contact time needs further evaluation. However, we recognise 17 Skinner T, Carey M, Cradock S, Daly H, Davies M, Doherty Y, et al. Diabetes education
and self-management for ongoing and newly diagnosed (DESMOND): process modelling
that additional support through increased contact time and of pilot study. Patient Educ Couns 2006;64:369-77.
frequency may incur additional benefit through important 18 Davies M, Heller S, Skinner T, Campbell M, Carey M, Cradock S, et al, on behalf of the
Diabetes Education and Self Management for Ongoing and Newly Diagnosed Collaborative.

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BMJ 2012;344:e2333 doi: 10.1136/bmj.e2333 (Published 26 April 2012) Page 6 of 12

RESEARCH

What is already known on this topic


The diabetes national service framework and NICE quality standards promote structured education for all from diagnosis of diabetes
Until now no studies have evaluated the long term impact of attending an education intervention

What this study adds


Differences in biomedical and lifestyle outcomes at 12 months from a structured group education programme for patients with newly
diagnosed type 2 diabetes were not sustained at three years, although illness beliefs remained significant
The results support the model of an ongoing education programme, although the optimum interval and contact time needs further
evaluation

Effectiveness of the diabetes education and self management for ongoing and newly 32 The DAFNE Study Group. Training in flexible, intensive insulin management to enable
diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE)
cluster randomised controlled trial. BMJ 2008;336:491-5. randomised controlled trial. BMJ 2002;325:746-9.
19 Khunti K, Skinner T, Heller S, Carey M, Dallosso H, Davies M. Biomedical, lifestyle and 33 Speight J, Amiel S, Bradley C, Heller S, Oliver L, Roberts S, et al. Long-term biomedical
psychosocial characteristics of people newly diagnosed with type 2 diabetes: baseline and psychosocial outcomes following DAFNE (Dose Adjustment for Normal Eating)
data from the DESMOND randomized controlled trial. Diabet Med 2008;25:1454-61. structured education to promote intensive insulin therapy in adults with sub-optimally
20 Gillett M, Dallasso H, Dixon S, Brennan A, Carey M, Campbell M, et al. Delivering the controlled type 1 diabetes. Diabet Res Clin Pract 2010;89:22-9.
diabetes education and self management for ongoing and newly diagnosed (DESMOND) 34 Deakin T, Cade J, Williams R, Greenwood D. Structured patient education: the Diabetes
programme for people with newly diagnosed type 2 diabetes: cost effectiveness analysis. X PERT Programme makes a difference. Diabet Med 2006;23:944-54.
BMJ 2010;341:c4093. 35 Trento M, Gamba S, Gentile L, Grassi G, Miselli V, Morone G, et al. Rethink Organisation
21 Minet L, Moller S, Vach W, Wagner L, Henrisken J. Mediating the effect of self-care to iMprove Education and Outcomes (ROMEO): a multicentre randomised trial of lifestyle
management intervention in type 2 diabetes: a meta-analysis of 47 randomised controlled intervention by group care to manage type 2 diabetes. Diabetes Care 2010;33:745-74.
trials. Patient Educ Couns 2010;80:29-41. 36 Hornsten A, Stenlund H, Lundman B, Sandstom H. Improvements in HbA1c remain after
22 Leventhal H, Meyer D, Nerenz D. The common-sense representation of illness danger. 5 yearsa follow up of an educational intervention focusing on patients personal
Contributions to medical psychology. Pergamon, 1980. understandings of type 2 diabetes. Diabet Res Clin Pract 2008;81:50-5.
23 Chaiken S, Wood W, Eagly A. Principles of persuasion. In: Higgih EKA, ed. Social 37 Craig C, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and
psychology: handbook of basic principles. Guilford Press, 1996. evaluating complex interventions: the new Medical Research Council guidelines. BMJ
24 Bandura A. Self-efficacy: toward a unifying theory of behavioural change. Psychol Rev 2008;337:1655.
1977;84:191-215. 38 Naik A, Palmer N, Peters N, Street R, Rao R, Suarez-Almazor M, et al. Comparative
25 Anderson R, Funnell M, Butler P, Arnold M, Fitzgerald J, Feste C. Patient empowerment. effectiveness of goal setting in diabetes mellitus group clinics. Arch Intern Med
Results of a randomized controlled trial. Diabetes Care 1995;18:943-9. 2011;171:453-9.
26 Anderson R. Patient empowerment and the traditional medical model. A case of 39 Gaede P, Lunde-Andersen H, Parving H-H, Pedersen O. Effect of a multifactorial
irreconcilable differences? Diabetes Care 1995;18:412-5. intervention on mortality in type 2 diabetes. N Engl J Med 2008;358:580-91.
27 Skinner T, Howells L, Greene S, Edgar K, McEvilly A, Johansson A. Development, reliability 40 Holman R, Paul S, Bethel M, Matthews D, Neil H. 10-year follow-up of intensive blood
and validity of the diabetes illness representations questionnaire: four studies with glucose control in type 2 diabetes. N Engl J Med 2008;359:1577-89.
adolescents. Diabet Med 2003;20:283-9.
28 Welch G, Jacobson A, Polonsky W. The problem areas in diabetes scale. An evaluation Accepted: 1 March 2012
of its clinical utility. Diabetes Care 1997;20:760-6.
29 Alshamsan R, Millett C, Majeed A, Khunti K. Has pay for performance improved the
management of diabetes in the United Kingdom? Primary Care Diabetes 2010;4:73-8. Cite this as: BMJ 2012;344:e2333
30 Griffin SJ, Borch-Johnsen K, Davies MJ, Khunti K, Rutten GEHM, Sandbk A, et al. This is an open-access article distributed under the terms of the Creative Commons
Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in
Attribution Non-commercial License, which permits use, distribution, and reproduction in
individuals with type 2 diabetes detected by screening (ADDITION-Europe): a
cluster-randomised trial. Lancet 2011;378:156-67. any medium, provided the original work is properly cited, the use is non commercial and
31 Egenmann C, Colagiuri R. Outcomes and indicators for diabetes educationa national is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-
consensus position. Diabetes Australia, 2007. nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

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BMJ 2012;344:e2333 doi: 10.1136/bmj.e2333 (Published 26 April 2012) Page 7 of 12

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Tables

Table 1| Baseline characteristics of participants with type 2 diabetes who were or were not followed up at three years. Values are means
(standard deviations) unless stated otherwise

Not followed up at 3 years Followed up at 3 years P values


Not followed
Intervention Intervention up v Group
Characteristics Total (n=220) (n=105) Control (n=115) Total (n=604) (n=332) Control (n=272) responders interaction
Age (years) 57.6 (12.5) 57.8 (12.9) 57.5 (12.2) 60.1 (11.8) 59.4 (11.6) 61.01 (12.1) 0.01 0.31
No (%) female 101 (45.9) 53 (50.5) 48 (41.7) 271 (44.9) 151 (45.5) 120 (44.1) 0.79 0.35
No (%) white European
ethnicity 182 (95.3) 91 (95.8) 91 (94.8) 543 (97.1) 307 (97.2) 236 (97.1) 0.22 0.81
No (%) smokers 34 (17.9) 15 (16.0) 19 (19.8) 76 (13.6) 42 (13.3) 34 (14.1) 0.15 0.68
HbA1c (%) 8.3 (2.2) 8.3 (2.2) 8.1 (2.1) 8.0 (2.1) 8.3 (2.2) 7.7 (1.9) 0.31 0.27
Total cholesterol (mmol/L) 5.4 (1.3) 5.3 (1.3) 5.5 (1.3) 5.3 (1.3) 5.4 (1.4) 5.3 (1.2) 0.58 0.12
High density lipoprotein
cholesterol (mmol/L) 1.2 (0.4) 1.2 (0.4) 1.2 (0.5) 1.2 (0.4) 1.2 (0.5) 1.2 (0.3) 0.86 0.29
Low density lipoprotein
cholesterol (mmol/L) 3.3 (1.2) 3.0 (1.0) 3.5 (1.3) 3.2 (1.1) 3.2 (1.1) 3.2 (1.0) 0.55 0.03
Triglycerides (mmol/L) 2.6 (2.0) 2.3 (1.8) 3.0 (2.1) 2.5 (2.1) 2.7 (2.6) 2.3 (1.4) 0.49 0.002
Systolic blood pressure
(mm Hg) 140.3 (19.0) 142.1 (19.5) 138.6 (18.3) 140.6 (17.1) 140.7 (18.1) 140.5 (15.9) 0.81 0.23
Diastolic blood pressure
(mm Hg) 82.3 (11.0) 83.0 (10.7) 81.6 (10.4) 81.6 (10.4) 82.3 (10.5) 80.7 (10.2) 0.39 0.98
Body weight (kg) 95.0 (22.1) 93.7 (21.6) 96.2 (22.5) 90.5 (18.6) 91.2 (18.3) 89.7 (18.9) 0.004 0.2
Body mass index 33.4 (6.7) 33.0 (6.4) 33.8 (7.0) 32.0 (6.0) 32.1 (5.9) 31.8 (6.1) 0.004 0.3
Waist circumference (cm) 108.4 (14.6) 108.5 (14.8) 108.3 (14.5) 105.3 (13.9) 104.8 (14.6) 105.9 (13.1) 0.008 0.59
Illness beliefs:
Coherence score 14.5 (4.2) 14.8 (4.3) 14.2 (4.3) 15.0 (4.2) 14.5 (4.1) 15.8 (4.2) 0.12 0.01
Timeline score 19.7 (3.7) 20.2 (3.6) 19.3 (3.8) 20.1 (4.0) 20.4 (3.9) 19.6 (4.1) 0.31 0.94
Responsibility score 23.9 (3.5) 23.8 (3.0) 24.0 (4.0) 24.4 (3.2) 24.4 (3.4) 24.5 (3.0) 0.06 0.93
Seriousness score 16.6 (2.4) 16.7 (2.4) 16.5 (2.3) 16.5 (2.7) 16.4 (2.7) 16.6 (2.7) 0.53 0.99
Impact score 14.8 (3.9) 14.8 (3.0) 14.8 (4.2) 14.2 (3.4) 14.1 (3.4) 14.4 (3.7) 0.05 0.75
HADS depression score 4.4 (3.7) 4.1 (3.4) 4.6 (4.0) 3.3 (3.3) 3.2 (3.1) 3.4 (3.1) <0.001 0.59

HADS=hospital anxiety and depression scale.

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BMJ 2012;344:e2333 doi: 10.1136/bmj.e2333 (Published 26 April 2012) Page 8 of 12

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Table 2| Changes in biomedical outcomes at three years

Change (95% CI)


Model summary, coefficient
Variables No (%) of participants Intervention group Control group (95% CI) P value
HbA1c (%) 585 (96.9) 1.32 (1.57 to 1.06) 0.81 (1.02 to 0.50) 0.02 (0.22 to 0.17) 0.81
Body weight (kg) 592 (98.0) 1.75 (2.48 to 1.03) 1.44 (2.42 to 0.45) 0.20 (1.33 to 0.93) 0.73
Total cholesterol (mmol/L) 589 (97.5) 1.20 (1.35 to 1.05) 1.07 (1.22 to 0.91) 0.03 (0.19 to 0.12) 0.68
High density lipoprotein cholesterol 367 (60.8) 0.01 (0.002 to 0.11) 0.07 (0.03 to 0.11) 0.02 (0.04 to 0.09) 0.51
(mmol/L)
Low density lipoprotein cholesterol 248 (41.1) 0.92 (1.12 to 0.72) 0.84 (1.05 to 0.63) 0.08 (0.28 to 0.13) 0.47
(mmol/L)
Triglyceride (mmol/L) 490 (81.1) 0.37 (0.94 to 0.40) 0.37 (0.56 to 0.18) 0.06 (0.27 to 0.15) 0.56
Systolic blood pressure (mm Hg) 595 (98.5) 7.88 (10.15 to 5.62) 6.58 (8.65 to 4.52) 1.07 (3.42 to 1.28) 0.37
Diastolic blood pressure (mm Hg) 595 (98.5) 6.03 (7.27 to 4.79) 4.45 (5.81 to 3.10) 0.68 (2.20 to 0.83) 0.38
Waist circumference (cm) 264 (43.7) 1.03 (2.43 to 0.37) 0.96 (3.62 to 1.70) 0.38 (4.43 to 3.66) 0.85
Body mass index 586 (97.0) 0.61 (0.87 to 0.36) 0.54 (0.90 to 0.18) 0.03 (0.45 to 0.39) 0.88
UKPDS 10 year coronary heart disease 322 (53.3) 7.80 (9.80 to 5.80) 6.49 (8.62 to 4.36) 1.67 (3.91 to 0.57) 0.14
risk
UKPDS 10 year cardiovascular disease 322 (53.3) 5.91 (8.10 to 3.72) 4.42 (6.89 to 1.95) 1.89 (5.17 to 1.39) 0.26
risk

UKPDS=United Kingdom Prospective Diabetes Study.

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BMJ 2012;344:e2333 doi: 10.1136/bmj.e2333 (Published 26 April 2012) Page 9 of 12

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Table 3| Summary of lifestyle outcomes at three years

Variables No (%) of participants Intervention group Control group Odds ratio (95% CI) P value
Non-smoker 457 (85.3) 253 (91.0) 183 (86.7) 2.07 (0.76 to 5.66) 0.16
Any level of physical activity 419 (78.2) 236 (92.9) 197 (91.2) 1.22 (0.60 to 2.48) 0.58

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BMJ 2012;344:e2333 doi: 10.1136/bmj.e2333 (Published 26 April 2012) Page 10 of 12

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Table 4| Scores for illness beliefs and hospital anxiety and depression scale

Median (interquartile range)


Variables No (%) of participants Intervention group Control group Model summary, coefficient (95% CI) P value
Illness coherence 409 (76.3) 20 (16-20) 19 (15-20) 0.93 (0.20 to 1.65) 0.01
Timeline 414 (77.2) 22 (20-25) 20 (19-25) 0.87 (0.24 to 1.49) 0.01
Personal responsibility 412 (76.9) 24 (23-27) 24 (23-26) 0.49 (0.004 to 0.99) 0.005
Impact 413 (77.1) 13 (12-15) 13 (12-15) 0.22 (0.33 to 0.77) 0.44
Seriousness 414 (77.2) 17 (15-19) 16 (15-18) 0.77 (0.23 to 1.30) 0.01
Depression 465 (86.8) 2 (1-5) 2 (1-6) 0.29 (0.74 to 0.15) 0.19
Problem areas in diabetes scale 461 (86.0) 10.0 (3.8-20.0) 8.8 (2.5-21.3) 0.69 (3.45 to 2.07) 0.63

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BMJ 2012;344:e2333 doi: 10.1136/bmj.e2333 (Published 26 April 2012) Page 11 of 12

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Table 5| Drugs used by participants with type 2 diabetes

Drugs Intervention group Control group P value


Antihypertensives 235 (70.8) 206 (76.9) 0.09
Lipid lowering 266 (80.1) 209 (78.0) 0.52
Antidepressants 24 (8.9) 18 (9.2) 0.90
Oral antidiabetics:
Monotherapy 188 (56.6) 107 (39.3) 0.32
Dual therapy 59 (17.8) 45 (16.5) 0.69
Insulin 10 (3.0) 7 (2.6) 0.75

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Figure

Flow of participants through trial

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